Expert Analysis

• Lessons From EdTech Provider's Data Breach Settlements

  

  Education technology company Illuminate Education's recent settlements with three states and the Federal Trade Commission over state privacy law claims following a student data breach are some of the first of their kind, suggesting a shift in enforcement focus to how companies handle student data and highlighting the potential for coordinated enforcement actions, say attorneys at Wilson Sonsini.

• What US Cos. Must Know To Comply With Italy's AI Law

  

  Italy's newly effective artificial intelligence law means U.S. companies operating in Italy or serving Italian customers must now meet EU AI Act obligations as well as Italy-specific requirements, including immediately enforceable criminal penalties, designated national authorities and sector-specific mandates, say attorneys at Portolano Cavallo.

• Insights From 2025's Flood Of Data Breach Litigation

  

  Several coherent patterns emerged from 2025's data breach litigation activity, suggesting that judges have grown skilled at distinguishing between companies that were genuinely victimized by sophisticated criminal actors despite reasonable precautions, and those whose security practices invited exploitation, says Frederick Livingston at McDonald Baas.

• The Next Pressure Point In Digital Health: Informed Consent

  

  Two new federal digital health initiatives will usher in a new era where virtual care, software-enabled devices and home-based monitoring are integrated into care and reimbursement models, with the impact of shifting rules and opportunities felt most immediately in the context of informed consent, says Kimberly Chew at Husch Blackwell.

• 4 Trends Shaping Drug And Medical Device Law For 2026

  

  2025 saw some significant legal developments with potential impact for drug and device manufacturers, ranging from growing skepticism in science and regulatory entities to new regulation of artificial intelligence, say attorneys at Faegre Drinker.

• Unique Aspects Of Texas' Approach To AI Regulation

  

  The Texas Responsible AI Governance Act — which will soon be the sole comprehensive artificial intelligence law in the U.S. — pulls threads from EU and Colorado laws but introduces more targeted rules with fewer obligations on commercial entities, say attorneys at MVA Law.

• Shutdown Imperils Telehealth Access For Medicare Patients

  

  The federal government shutdown that commenced on Oct. 1 coincided with the expiration of certain telehealth flexibilities that had preserved expansive access to telehealth services for Medicare beneficiaries following COVID-19, creating significant legal and financial uncertainty for healthcare providers and patients, say attorneys at Robinson & Cole.

• How Courts May Interpret Data-Driven Healthcare Fraud Suits

  

  As the U.S. Department of Justice and other agencies increasingly turn to data mining as an enforcement tool, courts will have to determine how far data alone can take a fraud case, and sound theory, clinical expertise and institutional context will play an important role, say Jaime Jones at Sidley and Andrée-Anne Fournier and Atang Gilika at Analysis Group.

• Drug Ad Crackdown Demonstrates Admin's Aggressive Stance

  

  Recent actions by the U.S. Food and Drug Administration and U.S. Department of Health and Human Services targeting pharmaceutical companies' allegedly deceptive advertising practices signal an active — potentially even punitive — intent to regulate direct-to-consumer advertising out of existence, say attorneys at King & Spalding.

• Transmission Security Has A Critical Role In Healthcare

  

  In light of the U.S. Department of Health and Human Services' Office of Civil Rights' continuing enforcement initiative focusing on businesses' accurate and thorough security risk assessments under the Health Insurance Portability and Accountability Act, covered entities should not neglect the importance of transmission security, says John Howard at Clark Hill.

• When AI Denies, Insurance Bad Faith Claims May Follow

  

  Two recent rulings from Minnesota and Kentucky federal courts signal that past statements about claims-handling practices may leave insurers using artificial intelligence programs in claims administration vulnerable to suits alleging bad faith and unfair trade practices, say attorneys at Cozen O'Connor.

• DOJ's Novel Cybersecurity FCA Case Is A Warning To Medtech

  

  The U.S. Department of Justice's recent False Claims Act settlement with Illumina over alleged cybersecurity deficiencies suggests that enforcement agencies and whistleblowers are focusing attention toward cybersecurity in life sciences and medical tech, but also reveals key unanswered questions about the legal viability of such allegations, say attorneys at Morgan Lewis.

• Federal AI Action Plan Marks A Shift For Health And Bio Fields

  

  The Trump administration's recent artificial intelligence action plan significantly expands federal commitments across biomedical agencies, defining a pivotal moment for attorneys and others involved in research collaborations, managing regulatory compliance and AI-related intellectual property, says Mehrin Masud-Elias at Arnold & Porter.